CClinicalTrials.gg
RecruitingNCT07109440FOAMUpdated Aug 7, 2025

The Role of the Imaging FAPI PET/CT in Exploring the Microenvironment of Colorectal Cancer Liver Metastases

An interventional study of FAPI PET/CT in Liver Metastases From Colorectal Cancer, sponsored by Jules Bordet Institute. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by Jules Bordet Institute · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

FAPI PET/CT molecular imaging represents a cutting-edge advancement in oncological imaging, particularly for the preoperative assessment of colorectal liver metastases (CRLM). Fibroblast activation protein inhibitors (FAPIs), which are the focus of this imaging modality, selectively target cancer-associated fibroblasts, a critical component of the tumor microenvironment. FAPI PET/CT could be useful in the detection of HGP (Histological Growth Pattern) and in the changes during neoadjuvant chemotherapy prior to surgery

Read the detailed description

The tumor microenvironment (TME) plays an important role in tumor development and therapeutic response. The understanding of the TME components, especially cancer-associated fibroblasts (CAFs) remains limited. CAFs are among the most abundant and versatile components of the tumor stroma and they are implicated in all the hallmarks of cancer. They have a heterogenous phenotype within a single cell. Some CAFs may have immunosuppressive properties. In liver, there are two obvious physiological sources of CAFs: resident portal fibroblasts (PFs) and hepatic stellate cells (HSCs) . A recent study showed that based on the gene expression profile there are three major subsets of CAFs in colorectal primary tumors and in liver metastasis, including secretory CAFs, ECM-remodeling CAFs and contractile CAFs . In patients undergoing resection of colorectal liver metastasis (CRLMs) the histological growth patterns (HGP) reflect tumor biology and local infiltrating behavior . The HGPs of liver metastases reflect the ways in which cancer cells interact with the surrounding liver. The transition from one HGP to another could occur in patients with CRLM following systemic treatment .

FAPI PET/CT molecular imaging represents a cutting-edge advancement in oncological imaging, particularly for the preoperative assessment of colorectal liver metastases (CRLM). Fibroblast activation protein inhibitors (FAPIs), which are the focus of this imaging modality, selectively target cancer-associated fibroblasts, a critical component of the tumor microenvironment. FAPI PET/CT could be useful in the detection of HGP and in the changes during neoadjuvant chemotherapy prior to surgery

02

Conditions studied

  • Liver Metastases From Colorectal Cancer

Keywords

  • liver metastases from colorectal cancer
  • FAPI PET/CT
  • HGP
  • CAF
03

In context

Lead sponsor

Jules Bordet Institute is the lead sponsor of 103 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age above 18 years.
  • Liver metastasis on standard imaging for the initial assessment (MRI, FDG PET/CT)
  • Naïve for treatment or after neoadjuvant chemotherapy
  • Scheduled for liver metastasis resection
  • ECOG Performance status ≤2.
  • Signed written informed consent

Exclusion criteria

Exclusion Criteria:

  • Non-resectable liver metastases
  • Pregnant and lactating women
  • Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    patient with liver metastasis from colorectal cancer

    Diagnostic Test: FAPI PET/CT

Interventions

  • Diagnostic testFAPI PET/CT

    Patient will undergo FAPI PET/CT Prior to surgery

06

What researchers measure

Primary outcomes

  1. The quantification of IHC staining for FAP-expressing CAFs measured in patient-derived tissue specimens

    Time frame: from the enrollement to the surgery date, approximately 3 to 4 weeks

  2. The quantification of FAP expression on FAPI PET/CT (SUVmax, SUVmean, MTV [metabolically active tumor volume], FAPI-TV [FAPI positive tumour load])

    Time frame: From enrollment to surgery date, approximately 3 to 4 weeks

  3. correlation between the value of FAPI PET/CT and the percent encapsulated, and the HGP scores (desmoplastic, replacement, pushing) of the liver metastasis

    Time frame: from the enrollment to the anapathological analysis date,approximately 4 to 5 weeks

Secondary outcomes

  1. Correlation between FAPI PET/CT and FDG PET/CT parameters: (SUV max, SUVmean, metabolical volume)

    Time frame: from enrollment to the surgery date, approximately 3 to 4 weeks

  2. Correlation between FAPI metabolical volume and MRI tumor volume

    Time frame: from enrollment to the surgery date, approximately 3 to 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Institut Jules Bordet
    Brussels, 1070, Belgium
    • Irina Ortansa Vierasu, MD · Contact · o-i.vierasu@hubruxelles.be · 02.555.82.80
    • Loubna TARAJI, MS · Contact · 02.541.3781
    • Irina Ortansa Vierasu, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07109440
Lead sponsor
Jules Bordet Institute
Responsible party
Sponsor
First posted
Aug 7, 2025
Start date
May 9, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 7, 2025

Study contacts

Loubna Taraji, MS
Contact
loubna.taraji@hubruxelles.be
02.541.37.81

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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